An adult ingested 400 mg chlorpheniramine with no
reported serious adverse effects. Toxic psychosis, a possible class effect from
overdose of sedating antihistamines, has been reported with accidental overdose
of chlorpheniramine.

Treatment of overdosage consists of discontinuation of
Vituz Oral Solution together with institution of appropriate therapy. Primary
attention should be given to the reestablishment of adequate respiratory
exchange through provision of a patent airway and the institution of assisted
or controlled ventilation. The opioid antagonist naloxone hydrochloride is a
specific antidote for respiratory depression which may result from overdosage
or unusual sensitivity to opioids including hydrocodone. Therefore, an appropriate
dose of naloxone hydrochloride should be administered, preferably by the
intravenous route, simultaneously with efforts at respiratory resuscitation.
For further information, see full prescribing information for naloxone
hydrochloride. An antagonist should not be administered in the absence of
clinically significant respiratory depression. Oxygen, intravenous fluids,
vasopressors, and other supportive measures should be employed as indicated.
Gastric emptying may be useful in removing unabsorbed drug.

Hemodialysis is not routinely used to enhance the
elimination of chlorpheniramine from the body. Urinary excretion of
chlorpheniramine is increased when the pH of the urine is acidic; however, acid
diuresis is NOT recommended to enhance elimination in overdose, as the risks of
acidemia and acute tubular necrosis in patients with rhabdomyolysis far
outweigh any potential benefit.

CONTRAINDICATIONS

Vituz Oral Solution is contraindicated in:

Patients with known
hypersensitivity to hydrocodone bitartrate, chlorpheniramine maleate or any of the inactive ingredients of Vituz Oral Solution.

Patients receiving MAOI therapy
or within 14 days of stopping such therapy.